Penicillin Allergy Delabeling Among Surgical Patients | NCT05956080

Studies
Penicillin Allergy Delabeling Among Surgical Patients

NCT05956080

Sponsor

University Medicine Greifswald

Status

Unknown status

Last Update Posted

Jul 21, 2023Actual

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Penicillin Allergy

Interventions

Allergy testing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Estimated

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Jul 13, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2023

Last Update Posted Date

Jul 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Allergy testing	Other		Diagnostic Test: Allergy testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allergy testing	Diagnostic Test	University Medicine Greifswald	Allergy testing

Measure	Description	Time Frame
Confirmed penicillin allergy		1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgical patients with reported penicillin allergy

Exclusion Criteria:

missing consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sebastian Gibb, MD	Contact	00493834 86 5801		sebastian.gibb@med.uni-greifswald.de

Overall Officials

Name	Affiliation	Role
Sebastian Gibb, MD	University Medicine Greifswald	Principal Investigator
Christian S. Scheer, MD	University Medicine Greifswald	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012882	Skin Tests

Ancestor Terms

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided